K173932

Substantially Equivalent

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

Applicant: Alere Scarborough, Inc.
Product code: OCC
Advisory panel: Microbiology
Date received: 2017-12-26
Decision date: 2018-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.